Limited coverage criteria – cladribine

Last updated on April 23, 2026

 

Return to Special Authority drug list 

Generic name

cladribine

Strength & form

10 mg tablet

Special Authority criteria

Approval period

As first-line monotherapy for the treatment of adults (18 years of age and older) with relapsing-remitting multiple sclerosis (RRMS) who meet ALL of the following criteria:

  • Diagnosis according to the current clinical criteria and magnetic resonance imaging (MRI) evidence

AND

  • Special Authority request is submitted by a neurologist from a designated MS clinic3

AND

  • Patient is ambulatory with or without aid (Expanded Disability Status Scale [EDSS] of 6.5 or less)

2 years (2 treatment courses)1,2

Practitioner exemptions

  • Collaborative Prescribing Agreement (CPA) (PDF, 144KB) is available to neurologists specializing in MS whose primary place of practice is a designated MS clinic. Neurologists who have signed a CPA are not required to submit a Special Authority request form for coverage
  • Each CPA must be signed by the neurologist who is requesting coverage (not a delegate)

Special notes

  • 1Cladribine is given as 2 treatment courses over 2 years (cumulative dose of 3.5 mg/kg body weight over 2 years). Each treatment course (1.75 mg/kg body weight per year) consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year. A treatment week is given for 4 or 5 days. Total duration of treatment over the 2 years is 4 weeks (2 weeks per year)
  • 2PharmaCare coverage is limited to two courses of treatment per lifetime. The efficacy of cladribine for treatment duration beyond 2 years has not been established
  • 3The patient is under the care of a specialist (neurologist from a designated MS clinic) who has experience in the diagnosis and management of RRMS

Special Authority request form(s)